Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study

This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. The investigators will recruit a healthy participant and conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or without caffeine consumption before the stimulation. Moreover, the experiment will be conducted at different times of the day (morning or afternoon)

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: caffeine; Other: Experimental time

Detailed Description

One healthy participant will be recruited for this study. The participants will be subjected to concurrent TBS/fNIRS, to which the iTBS will be applied on the left DLPFC and the NIRS will measure the prefrontal hemodynamic response simultaneously.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Right-handed

Exclusion Criteria:

• history of epilepsy, seizures, or convulsions
• current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
• current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
• with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cortical hemodynamic variability of four weeks iTBS; One healthy participant will be included in this study, which lasts for 4 weeks, 5 visits per week, involving 20 visits in total. The participant will receive the following instructions the night before: to take 200 mg of caffeine one hour before the visit (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the visit; to attend the visit in the morning or afternoon. These assignments will be randomized in a counterbalanced manner.

Other: caffeine; The investigators will ask participant to only intake 200 mg of caffeine one hour before the experiment (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the experiment; Other: Experimental time; The investigators will ask participant to attend the experiment in the morning or afternoon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenated hemoglobin (HbO) change compared to baseline	iTBS-induced HbO change in the DLPFC before, during and after stimulation	During and post TBS-fNIRS measurement, up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deoxygenated hemoglobin (HbR) change compared to baseline	iTBS-induced HbO change in the DLPFC before, during and after stimulation	During and post TBS-fNIRS measurement, up to 1 month
Oxygen saturation change compared to baseline	iTBS-induced HbO change in the DLPFC before, during and after stimulation	During and post TBS-fNIRS measurement, up to 1 month

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Georg S Kranz, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Theta-Burst stimulation (iTBS); Functional near-infrared spectroscopy (fNIRS); Concurrent TMS/fNIRS; Prefrontal hemodynamic response; Longitudinal effects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: HSEARS20200120005-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No